Hankin R
Pharmaceuticals Unit, Commission of the European Communities, Brussels.
Dev Biol Stand. 1992;79:3-9.
Although Community legislation has only recently been extended to cover veterinary biologicals, these products are fully covered by the recent Commission proposals for the free movement of medicinal products after 1992. The proposals are based on more than 25 years of harmonization of national regulations and more than 10 years' experience of coordinating national decisions on individual medicinal products. The proposals envisage the establishment of two new Community authorization procedures: a centralized procedure based on a single scientific evaluation of the highest possible quality to be undertaken within a new European Medicines Evaluation Agency, leading to a binding EEC-wide decision, with the possibility of limited exceptions to take account of differences in disease status in the Member States; a decentralized procedure based on the concept of mutual recognition of national decisions, with binding Community arbitration in the event of a dispute. To provide the Community institutions with the scientific and technical resources necessary to operate these new procedures, the proposals also provide for the establishment of a European Medicines Evaluation Agency.
尽管共同体立法直到最近才扩展至涵盖兽用生物制品,但这些产品完全涵盖在委员会最近关于1992年后药品自由流通的提案之中。这些提案基于25年以上各国法规协调工作以及10年以上协调各国关于个别药品决策的经验。提案设想设立两种新的共同体授权程序:一种是集中程序,该程序基于在新的欧洲药品评估局内进行的尽可能高质量的单一科学评估,从而得出具有约束力的全欧共体范围的决定,并有可能存在有限的例外情况以考虑成员国疾病状况的差异;另一种是分散程序,该程序基于各国决定相互认可的概念,在发生争议时由共同体进行有约束力的仲裁。为向共同体机构提供实施这些新程序所需的科学和技术资源,提案还规定设立一个欧洲药品评估局。